[Federal Register Volume 59, Number 8 (Wednesday, January 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-762]


[[Page Unknown]]

[Federal Register: January 12, 1994]


-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300318; FRL-4751-7]
RIN No. 2070-AC18

 

Maleic Acid Monoethyl Ester-Vinyl Methyl Ether Copolymer, Maleic 
Acid Monoisopropyl Ester-Vinyl Methyl Ether Copolymer, Maleic Acid 
Monobutyl Ester-Vinyl Methyl Ether Copolymer; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes exemptions from the requirement of a 
tolerance be established for residues of maleic acid monoethyl ester-
vinyl methyl ether copolymer, maleic acid monoisopropyl ester-vinyl 
methyl ether copolymer, and maleic acid monobutyl ester-vinyl methyl 
ether copolymer when used as inert ingredients (seed-coating adhesives, 
gels, and antitranspirants) in pesticide formulations applied to 
growing crops, raw agricultural commodities after harvest, and animals. 
This proposed regulation was requested by International Specialty 
Products.

DATES: Written comments, identified by the document control number 
[OPP-300318], must be received on or before February 11, 1994.

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, bring 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 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: Connie Welch, Registration 
Division (7505C), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: 2800 
Crystal Drive, North Tower, 6th Floor, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, (703)-308-8320.

SUPPLEMENTARY INFORMATION: International Specialty Products, 1361 Alps 
Rd., Wayne, NJ 07470, has submitted to EPA the following pesticide 
petitions (PPs): (1) 3E4243, maleic acid monoethyl ester-vinyl methyl 
ether copolymer; (2) 3E4248, maleic acid monisopropyl ester-vinyl 
methyl ether copolymer; and (3) 3E4247, maleic acid monobutyl ester-
vinyl methyl ether copolymer 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 
residues of these copolymers when used as inert ingredients (seed-
coating adhesives, gels, and antitranspirants) in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest, and 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 
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. Where it can be determined that the inert 
ingredient will present minimal or no risk, the Agency does not need 
some or all of the listed studies to rule on the proposed tolerance or 
exemption for an inert ingredient. The Agency has decided that any 
data, in addition to that described below, normally required to support 
the proposed tolerance exemption for maleic acid monoethyl ester-vinyl 
methyl ether copolymer, maleic acid monisopropyl ester-vinyl methyl 
ether copolymer, and maleic acid monobutyl ester-vinyl methyl ether 
copolymer will not 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. Maleic acid monoethyl ester-vinyl methyl 
ether copolymer, maleic acid monoisopropyl ester-vinyl methyl ether 
copolymer, and maleic acid monobutyl ester-vinyl methyl ether copolymer 
conform to the definition of polymers given in 40 CFR 723.250(b)(11) 
and meet the following criteria that are used to identify low-risk 
polymers:
    1. The minimum number average molecular weight of the copolymers 
mentioned above is 46,000. 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.
    2. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic 
acid monoisopropyl ester-vinyl methyl ether copolymer, and maleic acid 
monobutyl ester-vinyl methyl ether copolymer are not cationic polymers, 
nor are they reasonably anticipated to become cationic polymers in a 
natural aquatic environment.
    3. The above-mentioned copolymers do not contain less than 32.0 
percent by weight of the atomic element carbon.
    4. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic 
acid monisopropyl ester-vinyl methyl ether copolymer, and maleic acid 
monobutyl ester-vinyl methyl ether copolymer contain as integral parts 
of their composition the atomic elements carbon, hydrogen, nitrogen, 
and oxygen.
    5. The above-mentioned copolymers do not contain as integral parts 
of their composition, except as impurities, any elements other than 
those listed in 40 CFR 723.250(d)(3)(ii).
    6. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic 
acid monisopropyl ester-vinyl methyl ether copolymer; and maleic acid 
monobutyl ester-vinyl methyl ether copolymer are not biopolymers, 
synthetic equivalents of biopolymers, or derivatives or modifications 
of biopolymers that are substantially intact.
    7. The above-mentioned copolymers are not manufactured from 
reactants containing, other than as impurities, halogen atoms or cyano 
groups.
    8. Maleic acid monoethyl ester-vinyl methyl ether copolymer, maleic 
acid monisopropyl ester-vinyl methyl ether copolymer, and maleic acid 
monobutyl ester-vinyl methyl ether copolymer do not contain reactive 
functional groups that are intended or reasonably anticipated to 
undergo futher reaction.
    9. The above-mentioned copolymers are not designed, nor are they 
reasonable expected, to substantially degrade, decompose, or 
depolymerize.
    Based on the information above and review of its use, EPA has found 
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 exemptions 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, as amended, which contains any of these three 
chemicals may request, within 30 days after 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 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-300318]. 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.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 2 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 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 Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

Dated: December 23, 1993.

Stephen L. Johnson,
Acting Director, Registration Division, Office of Prevention, 
Pesticides and Toxic Substances.

    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. In Sec. 180.1001, by amending paragraphs (c) and (e) in the 
tables therein by adding and alphabetically inserting the following 
inert ingredients, to read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

* * * * *
    (c) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
                                 *******                                
Maleic acid monoethyl      ..................  Seed-coating adhesive,   
 ester-vinyl methyl ether                       gel, and                
 copolymer, CAS No. 25087-                      antitranspirant.        
 06-3, minimum average                                                  
 molecular weight 46,000                                                
Maleic acid monisopropyl   ..................  Seed-coating adhesive,   
 ester-vinyl methyl ether                       gel, and                
 copolmer, CAS No. 31307-                       antitranspirant.        
 95-6, minimum average                                                  
 molecular weight 49,000.                                               
Maleic acid monobutyl      ..................  Seed-coating adhesive,   
 ester-vinyl methyl ether                       gel, and                
 copolymer, CAS No. 25119-                      antitranspirant.        
 68-0, minimum average                                                  
 molecular weight 52,000.                                               
                                                                        
                                 *******                                
------------------------------------------------------------------------

* * * * *
    (e) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
                                 *******                                
Maleic acid monoethyl      ..................  Seed-coating adhesive,   
 ester-vinyl methyl ether                       gel, and                
 copolymer, CAS No. 25087-                      antitranspirant.        
 06-3, minimum average                                                  
 molecular weight 46,000.                                               
Maleic acid monisopropyl   ..................  Seed coating adhesive,   
 ester-vinyl methyl ether                       gel, and                
 copolmer, CAS No. 31307-                       antitranspirant.        
 95-6, minimum average                                                  
 molecular weight 49,000.                                               
Maleic acid monobutyl      ..................  Seed-coating adhesive,   
 ester-vinyl methyl ether                       gel, and                
 copolymer, CAS No. 25119-                      antitranspirant.        
 68-0, minimum average                                                  
 molecular weight 52,000.                                               
                                                                        
                                 *******                                
------------------------------------------------------------------------


[FR Doc. 94-762 Filed 1-11-94; 8:45 am]
BILLING CODE 6560-50-F