[Federal Register Volume 59, Number 8 (Wednesday, January 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-762]
[[Page Unknown]]
[Federal Register: January 12, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300318; FRL-4751-7]
RIN No. 2070-AC18
Maleic Acid Monoethyl Ester-Vinyl Methyl Ether Copolymer, Maleic
Acid Monoisopropyl Ester-Vinyl Methyl Ether Copolymer, Maleic Acid
Monobutyl Ester-Vinyl Methyl Ether Copolymer; Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes exemptions from the requirement of a
tolerance be established for residues of maleic acid monoethyl ester-
vinyl methyl ether copolymer, maleic acid monoisopropyl ester-vinyl
methyl ether copolymer, and maleic acid monobutyl ester-vinyl methyl
ether copolymer when used as inert ingredients (seed-coating adhesives,
gels, and antitranspirants) in pesticide formulations applied to
growing crops, raw agricultural commodities after harvest, and animals.
This proposed regulation was requested by International Specialty
Products.
DATES: Written comments, identified by the document control number
[OPP-300318], must be received on or before February 11, 1994.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document 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 comment 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. All
written comments will be available for public inspection in Rm. 1132 at
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Connie Welch, Registration
Division (7505C), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: 2800
Crystal Drive, North Tower, 6th Floor, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703)-308-8320.
SUPPLEMENTARY INFORMATION: International Specialty Products, 1361 Alps
Rd., Wayne, NJ 07470, has submitted to EPA the following pesticide
petitions (PPs): (1) 3E4243, maleic acid monoethyl ester-vinyl methyl
ether copolymer; (2) 3E4248, maleic acid monisopropyl ester-vinyl
methyl ether copolymer; and (3) 3E4247, maleic acid monobutyl ester-
vinyl methyl ether copolymer requesting that the Administrator pursuant
to section 408(e) of the Federal Food, Drug, and Cosmetic Act, 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 these copolymers when used as inert ingredients (seed-
coating adhesives, gels, and antitranspirants) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest, and 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.
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. Where it can be determined that the inert
ingredient will present minimal or no risk, the Agency does not need
some or all of the listed studies to rule on the proposed tolerance or
exemption for an inert ingredient. The Agency has decided that any
data, in addition to that described below, normally required to support
the proposed tolerance exemption for maleic acid monoethyl ester-vinyl
methyl ether copolymer, maleic acid monisopropyl ester-vinyl methyl
ether copolymer, and maleic acid monobutyl ester-vinyl methyl ether
copolymer will not need to be submitted. The rationale for this
decision is described below:
In the case of certain chemical substances that are defined as
``polymers,'' the Agency has established a set of criteria which
identify categories of polymers that present low risk. These criteria
(described in 40 CFR 723.250) identify polymers that are relatively
unreactive and stable compared to other chemical substances as well as
polymers that typically are not readily absorbed. These properties
generally limit a polymer's ability to cause adverse effects. In
addition, these criteria exclude polymers about which little is known.
The Agency believes that polymers meeting the criteria noted above will
present minimal or no risk. Maleic acid monoethyl ester-vinyl methyl
ether copolymer, maleic acid monoisopropyl ester-vinyl methyl ether
copolymer, and maleic acid monobutyl ester-vinyl methyl ether copolymer
conform to the definition of polymers given in 40 CFR 723.250(b)(11)
and meet the following criteria that are used to identify low-risk
polymers:
1. The minimum number average molecular weight of the copolymers
mentioned above is 46,000. Substances with molecular weights greater
than 400 generally are not absorbed through the intact skin, and
substances with molecular weights greater than 1,000 generally are not
absorbed through the intact gastrointestinal (GI) tract. Chemicals not
absorbed through skin or GI tract generally are incapable of eliciting
a toxic response.
2. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic
acid monoisopropyl ester-vinyl methyl ether copolymer, and maleic acid
monobutyl ester-vinyl methyl ether copolymer are not cationic polymers,
nor are they reasonably anticipated to become cationic polymers in a
natural aquatic environment.
3. The above-mentioned copolymers do not contain less than 32.0
percent by weight of the atomic element carbon.
4. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic
acid monisopropyl ester-vinyl methyl ether copolymer, and maleic acid
monobutyl ester-vinyl methyl ether copolymer contain as integral parts
of their composition the atomic elements carbon, hydrogen, nitrogen,
and oxygen.
5. The above-mentioned copolymers do not contain as integral parts
of their composition, except as impurities, any elements other than
those listed in 40 CFR 723.250(d)(3)(ii).
6. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic
acid monisopropyl ester-vinyl methyl ether copolymer; and maleic acid
monobutyl ester-vinyl methyl ether copolymer are not biopolymers,
synthetic equivalents of biopolymers, or derivatives or modifications
of biopolymers that are substantially intact.
7. The above-mentioned copolymers are not manufactured from
reactants containing, other than as impurities, halogen atoms or cyano
groups.
8. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic
acid monisopropyl ester-vinyl methyl ether copolymer, and maleic acid
monobutyl ester-vinyl methyl ether copolymer do not contain reactive
functional groups that are intended or reasonably anticipated to
undergo futher reaction.
9. The above-mentioned copolymers are not designed, nor are they
reasonable expected, to substantially degrade, decompose, or
depolymerize.
Based on the information above and review of its use, EPA has found
that, when used in accordance with good agricultural practice, these
ingredients are useful and a tolerance is not necessary to protect the
public health. Therefore, EPA proposes that the exemptions from the
requirement of a tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide under the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended, which contains any of these three
chemicals may request, within 30 days after publication of this
document in the Federal Register, that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the Federal Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [OPP-300318]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch, at the address given above from 8 a.m. to 4
p.m., Monday through Friday, except legal holidays.
The Office of Management and Budget has exempted this rule from the
requirements of section 2 of Executive Order 12866.
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 an 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: December 23, 1993.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Prevention,
Pesticides and Toxic Substances.
Therefore, it is proposed that 40 CFR part 180 be 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. In Sec. 180.1001, by amending paragraphs (c) and (e) in the
tables therein by adding and alphabetically inserting the following
inert ingredients, 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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Maleic acid monoethyl .................. Seed-coating adhesive,
ester-vinyl methyl ether gel, and
copolymer, CAS No. 25087- antitranspirant.
06-3, minimum average
molecular weight 46,000
Maleic acid monisopropyl .................. Seed-coating adhesive,
ester-vinyl methyl ether gel, and
copolmer, CAS No. 31307- antitranspirant.
95-6, minimum average
molecular weight 49,000.
Maleic acid monobutyl .................. Seed-coating adhesive,
ester-vinyl methyl ether gel, and
copolymer, CAS No. 25119- antitranspirant.
68-0, minimum average
molecular weight 52,000.
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* * * * *
(e) * * *
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Inert ingredients Limits Uses
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*******
Maleic acid monoethyl .................. Seed-coating adhesive,
ester-vinyl methyl ether gel, and
copolymer, CAS No. 25087- antitranspirant.
06-3, minimum average
molecular weight 46,000.
Maleic acid monisopropyl .................. Seed coating adhesive,
ester-vinyl methyl ether gel, and
copolmer, CAS No. 31307- antitranspirant.
95-6, minimum average
molecular weight 49,000.
Maleic acid monobutyl .................. Seed-coating adhesive,
ester-vinyl methyl ether gel, and
copolymer, CAS No. 25119- antitranspirant.
68-0, minimum average
molecular weight 52,000.
*******
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[FR Doc. 94-762 Filed 1-11-94; 8:45 am]
BILLING CODE 6560-50-F