[Federal Register Volume 61, Number 75 (Wednesday, April 17, 1996)]
[Proposed Rules]
[Pages 16747-16749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9476]
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DEPARTMENT OF TRANSPORTATION
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300419; FRL-5355-7]
RIN 2070-AB18
Pentaerythritol Stearates; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of a mixture of chemicals
known as pentaerythritol stearates (CAS Reg. No. 85116-93-4), which
include pentaerythritol monostearate (CAS Reg. No. 78-23-9),
pentaerythritol distearate (CAS Reg. No. 13081-97-5), pentaerythritol
tristearate (CAS Reg. No. 28188-24-1), and pentaerythritol
tetrastearate (CAS Reg. No. 115-83-3) be exempted from the requirement
of a tolerance when used as an inert ingredient (emulsifier) at a
concentration of no more than 25 ppm in pesticide formulations applied
to growing crops and to raw agricultural commodities after harvest.
This proposed regulation was requested by Wacker Silicones Corporation.
DATES: Comments, identified by the docket control number [OPP-300419],
must be received on or before May 17, 1996.
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. 1128, Crystal
Mall, Building #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. 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-300419]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in the
SUPPLEMENTARY INFORMATION unit of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
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: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703) 308-
8375; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Wacker Silicones Corporation, 3301 Sutton
Road, Adrian Michigan 49221-9397 submitted pesticide petition (PP)
number 4E04378 to EPA 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) by establishing an
exemption from the requirement of a tolerance for a mixture of
chemicals known as pentaerythritol stearates (pentaerythritol
monostearate (CAS Reg. No. 78-23-9), pentaerythritol distearate (CAS
Reg. No. 13081-97-5), pentaerythritol tristearate (CAS Reg. No. 28188-
24-1), and pentaerythritol tetrastearate (CAS Reg. No. 115-83-3) when
used as an emulsifier in pesticide formulations applied to growing
crops or to raw agricultural commodities after harvest. 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.
[[Page 16748]]
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 established data requirements which will be used to
evaluate the risks posed by the presence of an inert ingredient in a
pesticide formulation. Exemptions from some or all of the requirements
may be granted if it can be determined that the inert ingredient will
present minimal or no risk. The Agency has decided that the data
normally required to support the proposed tolerance exemption for these
pentaerythritol stearates will not need to be submitted. The rationale
for this decision is described below:
1. An acute rat oral toxicity study with an acute oral LD50 of
>2000 mg/kg demonstrates that the mixture of pentaerythritol stearates
is practically non-toxic to mammals.
2. The degradation products of pentaerythritol stearates (mono-,
di-, tri-, and tetrastearates) include pentaerythritol and the
naturally occurring fatty acid stearic acid, the residues of which have
already been exempted from the requirement of a tolerance under 40 CFR
180.1001(c).
3. Human dietary exposure to pentaerythritol stearates resulting
from the proposed use is expected to be negligible. These chemicals are
also expected to have negligible environmental effects.
4. Pentaerythritol stearates are currently used in substances
approved by the Food and Drug Administration for use as components of
adhesives, paper and paperboard used in packaging, transporting or
holding food under title 21 of the Code of Federal Regulations (CFR)
Secs. 175.105, 176.170, and 176.210.
Based on the very low acute toxicity, the anticipated degradation
products, the structure and physico-chemical properties of
pentaerythritol stearates, the expected levels in the formulations and
worst case dietary exposure assumptions, the Agency has determined that
these inert ingredients will not pose a risk to human health or the
environment under the proposed conditions of use.
Based upon the above information, review of their use, and low
environmental exposure, the Agency believes 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 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, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this 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-300419].
A record has been established for this rulemaking under docket
number [OPP-300419] (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 p.m., Monday through Friday, excluding legal holidays.
The public record is located in Rm. 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:
[email protected]
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 place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 of Executive Order 12866.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354 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, Recording and
recordkeeping requirements.
Dated: March 29, 1996.
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. Section 180.1001 is amended in paragraph (c) 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 ingredients Limits Uses
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* * * * * * *
Pentaerythritol stearates 25 ppm Emulsifier
mixture (CAS Reg. No. 85116-93-
4) which include
pentaerythritol monostearate
(CAS Reg. No. 78-23-9),
pentaerythritol distearate (CAS
Reg. No. 13081-97-5),
pentaerythritol tristearate
(CAS Reg. No. 28188-24-1), and
pentaerythritol tetrastearate
(CAS Reg. No. 115-83-3)
[[Page 16749]]
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[FR Doc. 96-9476 Filed 4-16-96; 8:45 am]
BILLING CODE 6560-50-F