[Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
[Proposed Rules]
[Pages 57377-57379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28182]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300401; FRL-4985-4]
RIN 2070-AC18
1,2-Ethanediamine, Polymer With Oxirane and Methyloxirane;
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 1,2-ethanediamine, polymer
with oxirane and methyloxirane (CAS Reg. No. 26316-40-5) when used as
an inert ingredient (surfactant and dispersing agent) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest and to animals, under 40 CFR 180.1001 (c) and
(e). The BASF Corp. requested this proposed regulation pursuant to the
Federal Food, Drug and Cosmetic Act (FFDCA).
DATES: Written comments, identified by the document control number
[OPP-300401], must be received on or before December 15, 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, deliver 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 4:30 p.m., Monday through Friday, excluding
legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [OPP-300401]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
proposed 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: Bipin Gandhi, 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)-308-8380; e-mail:
gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The BASF Corp., 3000 Continental Drive-
North, Mount Olive, NJ 07828-1234, has submitted a pesticide petition,
PP 5E04579, to EPA requesting that the Administrator, pursuant to
section 408(e) of the FFDCA (21 U.S.C. 346a(e)), propose to amend 40
CFR 180.1001 (c) and (e) by exempting 1,2-ethanediamine, polymer with
oxirane and methyloxirane (CAS Reg. No. 26316-40-5) when used as an
inert ingredient (surfactant and dispersing agent) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest and to animals, under 40 CFR 180.1001(c) and
(e). These inert ingredients meet the definition of polymers under 40
CFR 723.250(b) and the criteria listed in 40 CFR 723.250(e) that define
chemical substances that pose no unreasonable risks under section 5 of
the Toxic Substance Control Act (TSCA).
[[Page 57378]]
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 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
such 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 inert ingredient. The Agency has decided that no
data, in addition to that described below, for 1,2-ethanediamine,
polymer with oxirane and methyloxirane 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.
1,2-Ethanediamine, polymer with oxirane and methyloxirane conforms
to the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers:
1. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not
a cationic polymer, nor is it reasonably anticipated to become a
cationic polymer in a natural aquatic environment.
2. 1,2-Ethanediamine, polymer with oxirane and methyloxirane
contains as an integral part of its composition the atomic elements
carbon, hydrogen, oxygen, and nitrogen.
3. 1,2-Ethanediamine, polymer with oxirane and methyloxirane 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)(2)(ii).
4. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not
designed, nor is it reasonably anticipated to substantially degrade,
decompose, or depolymerize.
5. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not
manufactured or imported from monomers and/or other reactants that are
not already included on the TSCA Chemical Substance Inventory or
manufactured under an applicable TSCA section 5 exemption.
6. 1,2-Ethanediamine, polymer with oxirane and methyloxirane is not
a water-absorbing polymer.
7. The minimum number-average molecular weight of 1,2-
ethanediamine, polymer with oxirane and methyloxirane is 2,800.
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.
8. 1,2-Ethanediamine, polymer with oxirane and methyloxirane has a
number average molecular weight in the range of 2,800 to 10,000 daltons
and contains less than 10 percent oligomeric material below molecular
weights 500 and less than 25 percent oligomeric material below 1,000
molecular weight.
9. 1,2-Ethanediamine, polymer with oxirane and methyloxirane has a
combined (total) reactive group equivalent weight greater than or equal
to 1,000 for amines as functional groups.
Based on the information above and review of its uses, 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 for the polymer 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 the ingredient
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-300401]. 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
4:30 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [OPP-300401] (including comments and data 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.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
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 all comments received electronically into printed,
paper form as they are received and will be placed in the paper copies
of the official rulemaking record which also will include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in the ADDRESSES at the
beginning of this document.
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
[[Page 57379]]
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, Processed foods,
Reporting and recordkeeping requirements.
Dated: October 27, 1995,
Peter Caulkins,
Acting 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. In Sec. 180.1001 paragraphs (c) and (e) are amended in the
tables therein by adding and alphabetically inserting the inert
ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
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Inert ingredient Limits Uses
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* * * * * * *
1,2 Ethanediamine, polymer .............. Surfactant, dispersing
with oxirane and agent.
methyloxirane (CAS Reg. No.
26316-40-5) minimum number
average molecular weight
2,800 and the range of
number average molecular
weight is 2,800 to 10,000
daltons.
* * * * * * *
(e) * * *
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Inert ingredients Limits Uses
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* * * * * * *
1,2 Ethanediamine, polymer .............. Surfactant, dispersing
with oxirane and agent.
methyloxirane (CAS Reg. No.
26316-40-5) minimum number
average molecular weight
2,800 and the range of
number average molecular
weight is 2,800 to 10,000
daltons.
* * * * * * *
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[FR Doc. 95-28182 Filed 11-14-95; 8:45 am]
BILLING CODE 6560-50-F
