[Federal Register Volume 60, Number 206 (Wednesday, October 25, 1995)]
[Proposed Rules]
[Pages 54641-54643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26059]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300399; FRL-4981-2]
RIN 2070-AC18
Octadecanoic Acid, 12-Hydroxy-, Homopolymer, Octadecanoate;
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 octadecanoic acid, 12-
hydroxy-, homopolymer, octadecanoate (CAS Reg. No. 58128-22-6) when
used as an inert ingredient (surfactant and dispersing agent) in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest, under 40 CFR 180.1001(c). ICI Americas,
Inc., requested this proposed regulation pursuant to the Federal Food,
Drug and Cosmetic Act (FFDCA).
DATES: Written comments, identified by the document control number
[OPP-300399], must be received on or before November 24, 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-300399]. 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: Rita Kumar, 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-
[[Page 54642]]
8811; e-mail: kumar.rita@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: ICI Americas, Inc., Concord Plaza, 3411
Silverside Rd., P.O. Box 15391, Wilmington, DE 19850, submitted
pesticide petition (PP) 5E04506 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) by exempting octadecanoic acid, 12-hydroxy-, homopolymer,
octadecanoate from the requirement of a tolerance. Octadecanoic acid,
12-hydroxy-, homopolymer, octadecanoate, when used as an inert
ingredient (surfactant and dispersing agent) in pesticide formulations
applied to growing crops or to raw agricultural commodities after
harvest, under 40 CFR 180.1001(c), meets the definition of a polymer
under 40 CFR 723.250(b) and the criteria listed in 40 CFR 723.250(e)
that define a chemical substance that poses no unreasonable risk under
section 5 of the Toxic Substance Control Act (TSCA).
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
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 inert ingredient. The Agency has decided that no
data, in addition to that described below, for octadecanoic acid, 12-
hydroxy-, homopolymer, octadecanoate 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.
Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate 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. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate is
not a cationic polymer, nor is it reasonably anticipated to become a
cationic polymer in a natural aquatic environment.
2. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate
contains as an integral part of its composition the atomic elements
carbon, hydrogen, and oxygen.
3. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate 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. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate is
not designed, nor is it reasonably anticipated to substantially
degrade, decompose, or depolymerize.
5. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate 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. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate is
not a water-absorbing polymer.
7. The minimum number-average molecular weight of octadecanoic
acid, 12-hydroxy-, homopolymer, octadecanoate is 1,370 daltons.
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. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate has a
number average molecular weight of 1,370 and has an oligomeric material
less than 10 percent below MW 500 and less than 25 percent below MW
1,000.
9. Octadecanoic acid, 12-hydroxy-, homopolymer, octadecanoate does
not contain reactive functional groups that are intended or reasonably
anticipated to undergo further reaction.
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-300399]. 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.
A record has been established for this rulemaking under docket
number [OPP-300399] (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
[[Page 54643]]
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 section 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 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: September 27, 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(c) 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.
* * * * *
(c) * * *
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Inert ingredient Limits Uses
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* * * * * * *
Octadecanoic acid, 12-hydroxy- .............. Surfactant and
, homopolymer, octadecanoate dispersing agent.
(CAS Reg. No. 58128-22-6),
minimum number-average
molecular weight 1,370.
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[FR Doc. 95-26059 Filed 10-24-95; 8:45 am]
BILLING CODE 6560-50-F
