Acetic Acid Ethenyl Ester, Polymer with Ethenol and (greek-a)-
2-Propenyl-(greek-w>)-Hydroxypoly(Oxy-1,2-Ethanediyl); Tolerance Exemption
[Federal Register: March 22, 1995 (Volume 60, Number 55)]
[Proposed Rules]
[Page 15111-15113]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr95-35]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300380; FRL-4936-4]
RIN 2070-AC18
Acetic Acid Ethenyl Ester, Polymer with Ethenol and (a)-
2-Propenyl-(w)-Hydroxypoly(Oxy-1,2-Ethanediyl); Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish an exemption from the
requirement of a tolerance for residues of acetic acid ethenyl ester,
polymer with ethenol and (a)-2-propenyl-(w)-
hydroxypoly(oxy-1,2-ethanediyl) (CAS Reg. No. 137091-12-4), when used
as an inert ingredient (component of water-soluble film) in pesticide
formulations applied to growing crops only under 40 CFR 180.1001(d).
Japan Technical Information Center, Inc., requested this proposed
regulation on behalf of Nippon Gohsei (U.S.A.) Co., Ltd.
DATES: Written comments, identified by the document control number,
[OPP-300380], must be received on or before April 21, 1995.
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 will be included in the
public docket by EPA without prior notice. All written comments will be
available for public inspection in Rm. 1132 at the address given above,
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Support
Branch, Registration Division (7505W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: 2800 Crystal Drive, North Tower, 6th Floor, Arlington, VA
22202, (703) 308-8323.
SUPPLEMENTARY INFORMATION: Japan Information Center, Inc., 775 South
23rd St., Arlington, VA 22202, on behalf of Nippon Gohsei (U.S.A.) Co.,
Ltd., submitted pesticide petition (PP) 4EO4403 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 establishing an exemption from the requirement of a
tolerance for residues of acetic acid ethenyl ester, polymer with
ethenol and (a)-2-propenyl-(w)-hydroxypoly(oxy-1,2-
ethanediyl) (CAS Reg. No. 137091-12-4), when used as an inert
ingredient (component of water-soluble film) in pesticide formulations
applied to growing crops only under 40 CFR 180.1001(d).
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. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an [[Page 15112]] inert ingredient. The Agency has
decided that no data, in addition to that described below, for acetic
acid ethenyl ester, polymer with ethenol and (a)-2-propenyl-
(w)-hydroxypoly(oxy-1,2-ethanediyl) will 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. Acetic acid ethenyl ester, polymer with
ethenol and (a)-2-propenyl-(w)-hydroxypoly(oxy-1,2-
ethanediyl) conforms to the definition of a polymer given in 40 CFR
723.250(b)(11) and meets the following criteria that are used to
identify low-risk polymers.
1. The minimum number-average molecular weight of acetic acid
ethenyl ester, polymer with ethenol and (a)-2-propenyl-
(w)-hydroxypoly(oxy-1,2-ethanediyl) is 15,000. 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
tract. Chemicals not absorbed through skin or GI tract generally are
incapable of eliciting a toxic response.
2. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) is not a
cationic polymer, nor is it reasonably expected to become a cationic
polymer in a natural aquatic environment.
3. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) does not
contain less than 32.0 percent by weight of the atomic element carbon.
4. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) contains as an
integral part of its composition the atomic elements carbon, hydrogen,
nitrogen, and oxygen.
5. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) does not
contain as an integral part of its composition, except as impurities,
any elements other than those listed in 40 CFR 723.250(d)(3)(ii).
6. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) is not a
biopolymer, a synthetic equivalent of a biopolymer, or a derivative or
modification of a biopolymer that is substantially intact.
7. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) is not
manufactured from reactants containing, other than impurities, halogen
atoms or cyano groups.
8. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) does not
contain a reactive functional group that is intended or reasonably
expected to undergo further reaction.
9. Acetic acid ethenyl ester, polymer with ethenol and (a)-
2-propenyl-(w)-hydroxypoly(oxy-1,2-ethanediyl) is neither
designed nor reasonably expected to substantiaully 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, this
ingredient is useful, and a tolerance is not necessary to protect the
public health. Therefore, EPA proposes that the exemption 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 (FIFRA) as amended, that contains any of the
ingredients listed herein, may request within 30 days after the
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 FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [OPP-300380]. 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 requirement 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 Subject in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 8, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
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. Section 180.1001(d) is amended in the table therein by adding
and alphabetically inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
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Inert ingredient Limits Uses
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* * *
Acetic acid ethenyl ................ Component of water-
ester, polymer with soluble film.
ethenol and (a)-
2-propenyl-(w)-
hydroxypoly(oxy-1,2-
ethanediyl) (CAS Reg.
No. 137091-12-4);
minimum number average
molecular weight 15,000.
* * * *
* * *
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[[Page 15113]] * * * * *
[FR Doc. 95-6933 Filed 3-21-95; 8:45 am]
BILLING CODE 6560-50-F
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