[Federal Register Volume 59, Number 206 (Wednesday, October 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26470]
[[Page Unknown]]
[Federal Register: October 26, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300330C; FRL-4913-9]
RIN 2070-AB78
Methyl Vinyl Ether-Maleic Acid Copolymer and Methyl Vinyl Ether-
Maleic Acid Copolymer Calcium Sodium Salt; Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document modifies the uses and categories of exemptions
included in the recent regulation establishing an exemption from the
requirement of a tolerance for residues of methyl vinyl ether-maleic
acid copolymer (CAS Reg. No. 25153-40-6) and methyl vinyl ether-maleic
acid copolymer calcium sodium salt (CAS Reg. No. 62386-95-2) in order
to correctly list the exemptions and uses for these polymers. EPA is
establishing exemptions from the requirement of a tolerance for
residues of these polymers when used as inert ingredients (dispersants,
seed-coating adhesives) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest. International
Specialty Products requested this regulation.
EFFECTIVE DATE: This regulation becomes effective October 26, 1994.
ADDRESSES: Written objections, identified by the document control
number, [OPP-300330C], 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.
FOR FURTHER INFORMATION CONTACT: By mail: Tina Levine, 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: 2800 Crystal Drive,
North Tower, Arlington, VA 22202, (703)-308-8393.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 1994
(59 FR 43526), EPA issued a proposed rule that gave notice that
International Specialty Products (ISP), 1361 Alps Rd., Wayne, NJ 07470,
had submitted petitions (PPs 3E4260 and 3E4261) 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(c) and (e) by establishing an exemption from the requirement
of a tolerance for residues of methyl vinyl ether-maleic acid copolymer
(CAS Reg No. 25153-40-6) and methyl vinyl ether-maleic acid copolymer
calcium sodium salt (CAS Reg. No. 62386-95-2) when used as inert
ingredients (dispersants, seed-coating adhesives) in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest, or animals. For simplicity, the exemption from tolerance
under 40 CFR 180.1001(c) was requested for the seed-coating adhesive
use, which is only applicable to growing crops, as well as the
dispersant use, which could include post-harvest uses. The exemption
from tolerance under 40 CFR 180.1001(e) would apply to the use of the
inerts as dispersants in formulations applied to animals.
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 exemptions will protect the public health. Therefore, the
tolerance exemptions are 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).
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 of 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: September 28, 1994.
Lois Rossi,
Acting 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 is amended in paragraph (c) in the table
therein by revising the entry for methyl vinyl ether-maleic acid
copolymer and adding immediately thereafter the entry for methyl vinyl
ether-maleic acid copolymer calcium sodium salt and in paragraph (e) in
the table therein by adding and alphabetically inserting the entry for
methyl vinyl ether-maleic acid copolymer and revising the entry for
methyl vinyl ether-maleic acid copolymer calcium sodium salt, to read
as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Methyl vinyl ether-maleic .................. Dispersant, seed-coating
acid copolymer (CAS Reg. adhesive
No. 25153-40-6), minimum
number-average molecular
weight 75,000.
Methyl vinyl ether-maleic .................. Dispersant, seed-coating
acid copolymer calcium adhesive
sodium salt (CAS Reg.
No. 62386-95-2), minimum
number-average molecular
weight 900,000..
* * * * * * *
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* * * * *
(e) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Methyl vinyl ether-maleic .................. Dispersant
acid copolymer (CAS Reg.
No. 25153-40-6), minimum
number-average molecular
weight 75,000.
Methyl vinyl ether-maleic .................. Dispersant
acid copolymer calcium
sodium salt (CAS Reg.
No. 62386-95-2), minimum
number-average molecular
weight 900,000..
* * * * * * *
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[FR Doc. 94-26470 Filed 10-25-94; 8:45 am]
BILLING CODE 6560-50-F