[Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
[Proposed Rules]
[Pages 13476-13478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7448]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
RIN 2070-AB18
[OPP-300418; FRL-5355-6]
Oxidized Pine Lignin, Sodium Salt; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that oxidized pine lignin, sodium salt
(CAS Reg. No. 68201-23-0) be exempted from the requirement of a
tolerance when used as an inert ingredient (surfactant or adjuvant to
surfactant) in pesticide formulations. This proposed regulation was
requested by LignoTech USA, Inc.
DATES: Comments, identified by the docket control number [OPP-300418],
must be received on or before April 26, 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.
ADDRESSES: The Agency invites any interested person who has concerns
about the implementation of this action to submit written comments in
triplicate to: By mail: Program Resources Section, Public Response and
Program Resources Branch, Field Operations Division (7506C),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring comments to: Rm. 1132, Crystal Mall #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-300418.'' 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 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: LignoTech USA, Inc., 100 Highway 51 South,
Rothschild, WI 54474-1998 submitted pesticide petition (PP) number
5E04471 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) and (e) by establishing an
exemption from the requirement of a tolerance for oxidized lignin,
sodium salt when used as a surfactant or adjuvant to surfactant in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest or 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
[[Page 13477]]
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 inert ingredient. The Agency has decided that no
data, in addition to that described below, for oxidized lignin, sodium
salt will need to be submitted. The rationale for this decision is
described below:
1. Similar chemicals such as pine lignin (used as an absorbent) and
sulfonated kraft lignin/lignosulfonates (used as a surfactant or
related adjuvant to surfactant), are exempt from the requirement of a
tolerance when used in pesticide formulations applied to growing crops
or to raw agricultural commodities after harvest or to animals under 40
CFR 180.1001 (c) and (e).
2. Pine lignin, also known as kraft lignin, is a derivative of a
natural plant polymer, lignin, which is the most abundant polymer in
nature. Pine lignin is used as a raw material for oxidized kraft lignin
as well as a starting material for pine-kraft lignin-based
lignosulfonates. It is produced as a coproduct during the manufacture
of paper via the kraft pulping process.
3. The toxicological data show that pine lignin, sulfonated pine
lignin as well as oxidized pine lignin or lignosulfonates are of very
low acute toxicity (LD50 >2 to >5 g/kg in rats and LC50 >1000 to >3000
mg/l in fish).
4. Pine lignin is classified as toxicity category IV in a skin
irritation and eye irritation studies.
Based on the submitted toxicological data, physico-chemical
properties of the sodium salt of oxidized kraft lignin, its structural
similarity to related chemicals such as kraft lignin/lignosulfonates
and pine/kraft lignin that have already been exempted under 40 CFR
180.1001(c) and (e), and the review of its use, the Agency has found
that, when used as a surfactant or adjuvant to surfactant in pesticide
formulations applied preharvest, postharvest or to animals 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, 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-300418].
A record has been established for this proposal under docket
number ``OPP-300418'' (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 the proposal 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
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
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Recording and recordkeeping requirements.
Dated: March 13, 1996.
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 is amended by revising the table in paragraphs
(c) and (e) by adding and alphabetically inserting the inert
ingredient, oxidized pine lignin to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
[[Page 13478]]
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Inert ingredients Limits Uses
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* * * * * * *
Oxidized pine lignin, sodium Maximum of 2% of Surfactant or
salt (CAS Reg. No. 68201-23-0) formulation adjuvant to
surfactant
* * * * * * *
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* * * * *
(e) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Oxidized pine lignin, sodium Maximum of 2% of Surfactant or
salt (CAS Reg. No. 68201-23-0) formulation adjuvant to
surfactant
* * * * * * *
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[FR Doc. 96-7448 Filed 3-26-96; 8:45 am]
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