[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       
------------------------------------------------------------------------
                                                                        
     *        *        *        *        *        *        *            
Oxidized pine lignin, sodium      Maximum of 2% of    Surfactant or     
 salt (CAS Reg. No. 68201-23-0)    formulation         adjuvant to      
                                                       surfactant       
                                                                        
     *        *        *        *        *        *        *            
------------------------------------------------------------------------

    *  *  *  *  *
    (e) *  *  *

                                                                        
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses       
------------------------------------------------------------------------
                                                                        
     *        *        *        *        *        *        *            
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]
BILLING CODE 6560-50-F