[Federal Register Volume 61, Number 26 (Wednesday, February 7, 1996)]
[Proposed Rules]
[Pages 4621-4623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2233]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300410; FRL-4994-4]


Xanthan Gum-Modified, Produced by the Reaction of Xanthan Gum and 
Glyoxal; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes that xanthan gum-modified, produced by 
the reaction of xanthan gum and glyoxal (maximum 0.3% by weight) be 
exempted from the requirement of a tolerance when used as a surfactant 
in pesticide formulations. This proposed regulation was requested by 
Rhone-Poulenc, Inc., pursuant to the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: Comments, identified by the docket control number [OPP-300410], 
must be received on or before March 8, 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. 1132, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part of 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. The public docket is 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: [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-300410]. No 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: 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: Rhone-Poulenc, Inc., CN 7500, Cranbury, NJ 
08512-7500, has submitted pesticide petition (PP) 2E04084 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 xanthan gum, modified, produced by the 
reaction of xanthan gum and glyoxal (maximum 0.3% by weight) when used 
as a surfactant 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.
    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 

[[Page 4622]]
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 xanthan gum, modified, produced by the reaction of xanthan 
gum and glyoxal will need to be submitted. The rationale for this 
decision is described below:
    1. Xanthan gum-modified, is a glyoxal-treated xanthan gum that, 
while similar to xanthan gum, has improved dispersion properties.
    2. Xantham gum is a naturally occurring high molecular weight 
biopolysaccharide which is already exempted from the requirement of a 
tolerance when used as a thickener in pesticide formulations applied to 
growing crops or to raw agricultural commodities after harvest (40 CFR 
180.1001(c)) and when used in pesticide formulations applied to animals 
(40 CFR 180.1001(e)).
    3. Glyoxal is cleared for use as a component of coated or uncoated 
food contact surface paper and paperboard (21 CFR 176.180 (b)(2)).
    4. Hydrolysis of xantham gum-modified results in the formation of 
xanthan gum and sodium glycolate, which is toxicologically similar to 
oxalic acid.
    5. Based on an estimation of dietary exposure utilizing a worst-
case situation in which a pesticide formulation utilizes modified 
xanthan gum containing 0.3% glyoxal, the resultant dietary exposure to 
glyoxal would be considered to be of no toxicological concern.
    6. A pesticide formulation containing modified xanthan gum with a 
0.1 to 0.3% glyoxal concentration would typically contain from 2.9 to 
7.5 ppm (parts per million) glyoxal. At these levels, it is considered 
to be of low ecological effects or environmental fate concern.
    Based upon the above information 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, 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 FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
docket control number, [OPP-300410]. 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-300410] (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:
    [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, 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 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, Reporting and 
recordkeeping requirements.

    Dated: January 25, 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 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 requirements of a tolerance.

* * * * *
    (c) * * *

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         Ingredients                Limits                 Uses         
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         *        *        *        *        *        *        *        
Xanthan gum-modified,          Not more than     Surfactant             
 produced by the reaction of    0.5% of                                 
 xanthan gum and glyoxal        pesticide                               
 (maximum 0.3% by weight).      formulation.                            
                                                                        
         *        *        *        *        *        *        *        
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[[Page 4623]]

[FR Doc. 96-2233 Filed 2-6-96; 8:45 am]
BILLING CODE 6560-50-F